Țară: Regatul Unit
Limbă: engleză
Sursă: VMD (Veterinary Medicines Directorate)
Porcine respiratory and reproductive syndrome virus
Ceva Animal Health Ltd
QI09AD03
Porcine respiratory and reproductive syndrome virus
Lyophilisate and solvent for suspension for injection
POM-V - Prescription Only Medicine – Veterinarian
Pigs
Live Viral Vaccine
Expired
2020-02-26
Issued: February 2020 AN: 00939/2018 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Persovac lyophilisate and solvent for suspension for injection for pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose (1 ml) contains: ACTIVE SUBSTANCE: Live porcine reproductive and respiratory syndrome (PRRS) virus strain P120: 4.0 – 7.3 log 10 CCID 50 * *CCID 50 Cell culture infective dose 50% EXCIPIENT: For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Lyophilisate and solvent for suspension for injection Lyophilisate: off-white, homogeneous pellet. Solvent: clear aqueous solution. The reconstituted product is a white, opalescent liquid. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs (for fattening) 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For active immunisation of pigs from 3 weeks of age in a PRRS virus contaminated environment, in order to reduce viraemia associated with European PRRS virus strains (genotype 1) infection. Onset of immunity: 3 weeks post vaccination Duration of immunity: 24 weeks post vaccination In a laboratory trial in seronegative piglets vaccinated at the age of 32 days, a reduction of titre and overall nasal shedding was observed after a challenge 5 weeks after vaccination. 4.3 CONTRAINDICATIONS Do not use in PRRS naïve herds in which the presence of PRRSV has not been established using reliable diagnostic methods. Do not use in boars producing semen, as PRRS virus can be shed in semen. Issued: February 2020 AN: 00939/2018 Page 2 of 5 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Vaccinate healthy animals only. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Care should be taken to avoid the introduction of the vaccine strain into an area where PRRS virus is not already present. The vaccine strain is excreted and thus may infect the susceptible pigs in contacts with vaccinated animals for at least 7 weeks. To avoid this infection, it is advised to vaccinate all target pigs within a herd fr Citiți documentul complet